Project Leadership of Widler & Schiemann AG

Widler & Schiemann AG is a consultancy that provides our clients with experienced business professionals to deliver effective and productive business solutions. The following list represents just a selection of our projects:

Invented, led and shaped the Quality Risk Management strategy, concept and methodology for Clinical Trials and Drug Safety and drove the process and organizational design and implementation.

Led the re-engineering of the SOP management system at a large pharmaceutical company and together with a global software company introduced Structured Content Management (SCM) to SOP management in mid-size and start-up companies.

Led a Clinical Supply Chain optimization project on a global scale based on quality, compliance and operational risk management approach in order to consolidate the IMP processes after a merger.

Led the team for the analysis of an R&D strategy and organizational set up of a small US Biotech company including development of a restructuring plan and recommendations for a strategy shift.

Led Task Force for QA- & GCP- integration of the Japanese subsidiary development operations of a global pharmaceutical company.

Co-ordination, organization of and strategic guidance for more than 50 FDA, EMA, JPMA initiated inspections globally.

Developed, led and implemented the strategy for off-shoring all transactional disclosure activities to a third-party service provider to drive quality and optimize costs.